KUALA LUMPUR: Ivermectin cannot be used as a treatment against the Covid-19 virus until there is robust data on its efficacy and safety.
Dr Christopher Lee said this following a police report lodged against the health minister, Datuk Seri Dr Adham Baba, and his director-general, Tan Sri Dr Noor Hisham Abdullah, over the latter's refusal to use the anti-parasite drug in treating Covid-19 patients.
Lee, the national adviser on infectious diseases, retweeted an image of the report and said that it was ridiculous.
"Ivermectin should be studied as a treatment option. But until there's more robust data on the drug, it is not accepted as a standard of care and can only be used in a clinical trial setting."
He said that on its part, the ministry had commenced such studies in 12 public hospitals.
In the report, it was claimed that ministry officials and related parties refused to use the drug despite its alleged use in more than 30 countries and purported approval by medical experts.
The New Straits Times' Letters to Editor had received many queries from readers on why Ivermectin was not a treatment for Covid-19. They also wanted to know its efficacy.
The ministry and the Institute for Clinical Research (ICR) have started clinical trials to study the use and efficacy of Ivermectin for high-risk Covid-19 patients at 12 public hospitals. The trials were approved by the ministry's Medical Research and Ethics Committee on May 25, where the study compares Ivermectin treatment (specific dose with specific duration) with the standard of care alone.
The study involves 500 subjects from high-risk groups aged 50 and above admitted to public hospitals with mild or moderate Covid-19 symptoms (stage two to three).
Meanwhile, public health expert Datuk Dr Awang Bulgiba Awang Mahmud said doctors in Malaysia could not be forced into an off-label use of an unregistered drug.
He said to review research papers on the use of Ivermectin and its alleged success in treating Covid-19 patients, a lot of time and effort were needed.
"Some people take publications at face value, but that is not how evidence-based medicine works. It takes systematic reviews that most experts would not venture into due to lack of time and resources," he said, adding that literature reviews on these papers alone would not be enough.
Ivermectin is a United States Food and Drug Administration (FDA) approved anti-parasite drug.
It is widely used for treating neglected tropical diseases, including intestinal onchocerciasis (parasitic worm), strongyloidiasis (a kind of roundworm) and helminthiases (worm infection which causes morbidity to its host).
However, the evidence is inconclusive to recommend routine use of Ivermectin for Covid-19 patients.
On June 5, Dr Noor Hisham said the use of Ivermectin gained global attention due to some promising results from case studies and clinical trials.
He, however, said the FDA had not approved Ivermectin for use in treating or preventing Covid-19 in humans, and the World Health Organisation only recommended its use in a clinical trial setting, in which patients are monitored by clinicians and researchers.
The European Medicines Agency has issued similar advisories.
Universiti Malaya's Tropical Infectious Diseases Research and Education Centre director Professor Dr Sazaly Abu Bakar said the ministry should publish the clinical study's findings on Ivermectin to allow experts to review it.
"This would be a boost to transparency as it could allow us to conduct peer-reviews and address the public confidence on the reports by the authorities."
He said studies on drugs and their efficacy should include academics and experts outside the ministry or be carried out independently in the future.
"This is because the ministry is the regulator and its researchers are bound to it. As such, the public may perceive the study as biased."
He said the clinical study was sanctioned by the health minister or the director-general, and the reports were usually given to them before a decision could be made on whether the reports would be made public.
Sazaly said the limited number of published reports on clinical trials by the ministry suggested that the authorities needed to conduct more trials and regularly share the findings by publishing them in reputable peer-review journals.